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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K143296
Device Name AIA-PACK C-Peptide Control Set
Applicant
Tosoh Bioscience, Inc.
6000 Shoreline Ct., Suite 101
South San Franciso,  CA  94080
Applicant Contact Robert L Wick
Correspondent
Tosoh Bioscience, Inc.
6000 Shoreline Ct., Suite 101
South San Franciso,  CA  94080
Correspondent Contact Robert L Wick
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/17/2014
Decision Date 12/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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